# K100591: Sorbact

- Pathway: 510(k) (Traditional)
- Applicant: Abigo Medical AB
- Decided: Jan 24, 2011 after 328 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002599 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063059: Sorbact Wound Dressing, Abigo Medical AB (2007) Summary page 1.

## Indications for use
OTC: Sorbact Gel Wound Dressing is intended for use in the management of minor wounds (dry to low exuding). The dressing may be used on minor scrapes, cuts, sores and burns. Rx: Sorbact Gel Wound Dressing is intended for use in the management of dry to low exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers.

Source page: https://510kreport.com/device/K100591
Methodology: https://510kreport.com/methodology